ClearanceBrief
Company ยท US

True Indicating, LLC

FDA 510(k) clearances and medical device recalls filed under this name, 2020 to 2026. Name variants (Inc, Corp, punctuation) are merged.

6510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
JOJIndicator, Physical/Chemical Sterilization Process3
FRCIndicator, Biological Sterilization Process1
MTCIndicator, Chemical, Enzymatic, Sterilization Process1
QVBBiological Sterilization Indicator With Indirect Growth Detection1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jun 18, 2026K251559InstaTRU Instant Biological Indicator for Steam (IBI-05)
True Indicating, LLC
QVB
Jan 17, 2025K242860Type 5 Integrating Indicator for Steam (CSPN-15)
True Indicating, LLC
JOJ
Jun 26, 2024K233413Ultraphon Chemical Indicator (TRO-T and TRO-B)
True Indicating, LLC
JOJ
Dec 2, 2022K220778Chemical Indicator for Steam
True Indicating, LLC
JOJ
Dec 14, 2021K210481Instant 20s Indicator
True Indicating, LLC
MTC
Dec 28, 2020K200970Self-Contained Biological Indicator
True Indicating, LLC
FRC

Latest recalls

DateFirm and productCodeLinked 510(k)
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